Skip to content

Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

Effects of Adding Ivabradine in Patients With Cardiogenic Shock Requiring Inotropic Support

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05594342
Acronym
IVA-CS
Enrollment
200
Registered
2022-10-26
Start date
2022-07-01
Completion date
2023-01-01
Last updated
2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock, Heart Failure, Ischemic Heart Disease

Keywords

Heart Failure, Cardiogenic shock, Ivabradine

Brief summary

Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1 This study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.

Detailed description

Background and study rationale: Ivabradine is a Heart Rate (HR) lowering agent which acts by inhibiting the If current in the sinoatrial node. It is currently indicated in patients with chronic heart failure with reduced ejection fraction (HFrEF). Dobutamine is an inotropic drug used in cardiogenic shock patients and it is associated with an increase in HR and incidence of cardiac arrhythmias.2 However, studies have suggested that increased heart rate may be deleterious in decompensated HFrEF due to an inverted Bowditch-Treppe response. Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1, 2 Aim of the work: * This study aims to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support. * Design: Randomized open-label interventional clinical trial. Methods and patients: * Study Type: Interventional (Clinical Trial) * Estimated Enrollment: 200 participants * Allocation: Randomized * Perspective: Prospective Study * Intervention Model: Two Group Assignment * Masking: None (Open Label) * Primary purpose: Treatment * Official title: Ivabradine effects in cardiogenic shock requiring inotropic support (IVA-CS) * Start Date: 01 August 2022 * Estimated Primary Completion Date: 01 January 2023

Interventions

DRUGIvabradine 7.5Mg Tab

Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.

DRUGDOBUTamine Injectable Solution

Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute

Sponsors

The Young Investigator Group of Cardiovascular Research
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.

Exclusion criteria

* Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support. * Patients with no oral intake * Patients who refused to sign the consent

Design outcomes

Primary

MeasureTime frameDescription
Duration of hospital stayUp to 1 monthTotal duration of hospital stay calculated in days
Heart rate reductionUp to 7 daysAmount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate
Time of weaning from dobutamine infusionUp to 7 daysThe time needed to completely wean dobutamine infusion calculated in hours

Secondary

MeasureTime frameDescription
Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)Up to 1 monthAny ventricular arrhythmias will be documented
Supraventricular arrhythmiaUp to 1 monthAny supraventricular arrhythmias will be documented

Countries

Egypt

Contacts

Primary ContactAbdallah Almaghraby, PhD
dr.maghraby@gmail.com+201222851687
Backup ContactMahmoud Abdelnabi, MD
mahmoud.hassan.abdelnabi@gmail.com+18065897577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026